Magnetic navigation systems and methods

ABSTRACT

Systems and methods for forming a lesion on an endocardial tissue of a patient&#39;s heart involve placing an ablation assembly inside of the heart and adjacent to the endocardial tissue, and placing a guiding assembly outside of the heart. An ablation assembly includes an ablation element and a first attraction element, and a guiding assembly includes a second attraction element. First and second attraction elements can be attracted via magnetism. Techniques involve forming an ablation on the cardiac tissue of a patient&#39;s heart with an ablation element of the ablation assembly. Optionally, techniques may include moving the second attraction element of the guiding assembly relative to the patient&#39;s heart, so as to effect a corresponding movement of the ablation element of the ablation assembly.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/694,642 filed Sep. 1, 2017 (now U.S. Pat. No. 10,932,851, issued Mar.2, 2021) entitled “MAGNETIC NAVIGATION SYSTEMS AND METHODS,” which is acontinuation of U.S. application Ser. No. 13/862,996 filed Apr. 15, 2013(now U.S. Pat. No. 9,750,566, issued Sep. 5, 2017) entitled “MAGNETICNAVIGATION SYSTEMS AND METHODS,” which is a continuation of U.S. patentapplication Ser. No. 12/781,072 filed May 17, 2010 (now U.S. Pat. No.8,430,875 issued Apr. 30, 2013) entitled “MAGNETIC NAVIGATION SYSTEMSAND METHODS,” which is a nonprovisional application of, and claims thebenefit of the filing date of, U.S. Provisional Patent Application No.61/179,564, entitled “MAGNETIC NAVIGATION SYSTEMS AND METHODS,” filedMay 19, 2009 by Tamer Ibrahim et al., the entire disclosure of which isincorporated herein by reference for all purposes.

This application is related to U.S. Patent Application No. 60/939,201filed May 21, 2007, U.S. Patent Application No. 61/015,472 filed Dec.20, 2007, and U.S. patent application Ser. Nos. 12/124,743 and12/124,766 filed May 21, 2008. The entire content of each of thesefilings is incorporated herein by reference for all purposes.

BACKGROUND OF THE INVENTION

Embodiments of the present invention related to medical devices andmethods, and in particular to cardiac ablation systems and methods.

Atrial fibrillation (AF) is a common clinical condition, and presents asubstantial medical issue to aging populations. AF is costly to healthsystems, and can cause complications such as thrombo-embolism, heartfailure, electrical and structural remodeling of the heart, and evendeath.

For many years, the main treatment for atrial fibrillation (AF) involvedpharmacological intervention. More recently, the focus has shiftedtoward surgical or catheter ablation options to treat or effect a curefor AF. The ablation techniques for producing lines of electricalisolation are now replacing the so-called Maze procedure. The Mazeprocedure uses a set of transmural surgical incisions on the atria tocreate fibrous scars in a prescribed pattern. This procedure was foundto be highly efficacious but was associated with a high morbidly rate.The more recent approach of making lines of scar tissue with modemablation technology has enabled the electrophysiologist or cardiacsurgeon to create the lines of scar tissue more safely. Ideally,re-entrant circuits that perpetuate AF can be interrupted by theconnected lines of scar tissue, and the goal of achieving normal sinusrhythm in the heart may be achieved.

Triggers for intermittent AF and drivers for permanent AF can be locatedat various places on the heart, such as the atria. For example, wheretriggers or drivers are located near the pulmonary veins, it followsthat treatment may involve electrical isolation of the pulmonary veins.

Certain cardiac surgical procedures involve administering ablativeenergy to the cardiac tissue in an attempt to create a transmural lesionon the tissue. However, in some cases such methods may not be optimaldue to the formation of incomplete lesions, which do not effectivelycreate a conduction block in the tissue. Relatedly, some techniques maynot provide the desired positioning of an ablation element relative tothe tissue which is to be treated, or may only provide complicated andexpensive approaches that attempt to maintain the desired positioning.For example, some proposed techniques cannot adequately apply ablationto the moving tissue of a beating heart. Hence, there continues to be aneed for improved systems and methods that can simply and effectivelydeliver ablative energy to patient tissue in a uniform and reproduciblemanner.

Although these and other proposed treatments may provide real benefitsto patients in need thereof, still further advances would be desirable.For example, it would be desirable to provide improved systems andmethods for guiding and navigating various mechanisms that are used inendocardial ablation procedures. Embodiments of the present inventionprovide solutions that address the problems described above, and henceprovide answers to at least some of these outstanding needs.

BRIEF SUMMARY OF THE INVENTION

Advantageously, embodiments of the present invention provide techniquesfor applying endocardial lesions to tissue at or near the pulmonary vein(PV) ostia and other locations of the heart, to cause or enhanceconduction block at the junction of the PV and left atrium as well asother blocking lesions. Such techniques are well suited for use withpatients presenting with paroxysmal (focal) atrial fibrillation.Exemplary embodiments involve the administration of precisely controlledablative energy, or controlled power, to create reproducible, uniformtransmural lesions during cardiac surgery. Such techniques enable rapidand effective ablative lesions in a variety of clinical situations,including endocardial and epicardial ablations. By forming thetransmural ablations, surgeons are able to achieve conduction block inthe patient. Advantageously, embodiments of the present invention can beused to create complete lesion sets and reliably produce transmurallesions on a beating heart. According to embodiments disclosed herein,transmural lesions across the atrial wall can be performed reliably andefficiently.

Embodiments also includes ablation systems having an ablation energysource for providing energy to the ablation device. An ablation energysource is typically suited for use with ablation apparatus as describedherein using RF energy. With regard to RF ablation, a typical RFablation system includes a RF generator which feeds current to anablation device, including those described in this application,containing a conductive electrode for contacting targeted tissue. Theelectrical circuit can be completed by a return path to the RFgenerator, provided through the patient and a large conductive plate,which is typically in contact with the patient's back. Embodimentsencompass ablation using RF electrodes, including single RF ablationelectrodes. Although ablation energy is often described herein in termsof RF energy, it is understood that embodiments are not limited to suchablation modalities, and other kinds of ablation energy sources andablation devices may be used. Hence, with regard to the ablationtechniques disclosed herein, other suitable ablation elements ormechanisms, instead or in addition to an RF electrode, can be used.Embodiments of the present invention therefore encompass any of avariety of ablation techniques, including without limitation infraredlasers, high intensity focused ultrasound (HIFU), microwave,Cryoablation (killing or damaging the tissue by freezing), chemical orbiological agents, radiation, and the like. In some cases, an ablationmechanism can include an ablation element that transmits or delivers RFenergy to patient tissue. Optionally, suitable ablation elements cantransmit or deliver infrared laser energy, high intensity focusedultrasound (HIFU) energy, microwave energy, Cryoablation energy,chemical agents, biological agents, radiation energy, and the like.Embodiments encompass ablation mechanisms having multiple ablationelements, such as multiple RF electrodes. According to some embodiments,an ablation element may include a monopolar electrode. Relatedly, anablation element may include a bipolar electrode. Any of thesemodalities is well suited for use in endocardial ablation techniquesresulting in electrical isolation and transmurality.

With the appropriate use of magnetic elements, it is possible to createendocardial lesions by dragging an ablation element along theendocardium, within the heart. A guiding mechanism disposed on theoutside of the heart chamber can be used to maneuver an ablationmechanism disposed within the heart chamber. Advantageously, suchtechniques can enhance contact between an ablative element and theendocardial tissue or inner lining of the heart, even in a beatingheart. Permanent magnets are well suited for such use, althoughelectromagnets can also be used.

In a first aspect, embodiments of the present invention encompass methodof forming a lesion on an endocardial tissue of a patient's heart.Exemplary methods can include placing an ablation assembly inside of theheart and adjacent to the endocardial tissue, and placing a guidingassembly outside of the heart. The ablation assembly can include anablation element and a first attraction element, and the guidingassembly can include a second attraction element. Often, a magneticattraction is present between the first and second attraction elements.Methods can also include forming the ablation on the endocardial tissueof the patient's heart with the ablation element of the ablationassembly. In some cases, the first attraction element includes amagnetized element. In some cases, the second attraction elementincludes a magnetized element. Methods may also involve moving thesecond attraction element of the guiding assembly relative to thepatient's heart, so as to effect a corresponding movement of theablation element of the ablation assembly. According to someembodiments, the ablation element includes a radiofrequency ablationelement, an infrared laser ablation element, a high intensity focusedultrasound ablation element, a microwave ablation element, acryoablation ablation element, a chemical agent ablation element, abiological agent ablation element, a radiation ablation element, or thelike. The ablation element may for example include a monopolar electrodeor a bipolar electrode. In some cases, a guiding assembly includes anelongate wand, and the second attraction element is coupled with adistal portion of the elongate wand. The ablation assembly may includean elongate catheter, and the first attraction element can be coupledwith a distal portion of the elongate catheter. Optionally, the ablationelement can be coupled with the distal portion of the elongate catheter.

In another aspect, embodiments of the present invention encompasssystems for forming a lesion on an endocardial tissue of a patient'sheart. Exemplary systems can include an ablation assembly having anablation element and a first attraction element, and a guiding assemblyhaving a second attraction element, such that a magnetic attraction ispresent between the first and second attraction elements or the firstand second attraction elements are magnetically attractable toward eachother. In some cases, the first attraction element includes a magnetizedelement. In some cases, the second attraction element includes amagnetized element. According to some embodiments, the ablation elementincludes a radiofrequency ablation element, an infrared laser ablationelement, a high intensity focused ultrasound ablation element, amicrowave ablation element, a cryoablation ablation element, a chemicalagent ablation element, a biological agent ablation element, a radiationablation element, or the like. The ablation element may for exampleinclude a monopolar electrode or a bipolar electrode. In some cases, aguiding assembly includes an elongate wand, and the second attractionelement is coupled with a distal portion of the elongate wand. Theablation assembly may include an elongate catheter, and the firstattraction element can be coupled with a distal portion of the elongatecatheter. Optionally, the ablation element can be coupled with thedistal portion of the elongate catheter.

For a fuller understanding of the nature and advantages of the presentinvention, reference should be had to the ensuing detailed descriptiontaken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 1A-1H illustrate aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIG. 2 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIG. 3 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIG. 3A illustrates aspects of patient anatomy.

FIG. 4 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 5A-5F illustrate aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 6A-6E illustrate aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIG. 7 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 8A-8B illustrate aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIG. 9 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 10A-10C illustrate aspects of ablation treatment systems andmethods according to embodiments of the present invention.

FIG. 11 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIG. 12 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIG. 13 illustrates aspects of ablation treatment systems and methodsaccording to embodiments of the present invention.

FIGS. 14A-14D illustrate aspects of ablation treatment systems andmethods according to embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention encompass magnetic navigationsystems and methods for performing endocardial ablation in a patient inneed thereof. For example, such techniques are well suited for treatingpatients who present with atrial fibrillation and other electricalabnormalities of the heart such as incessant ventricular tachycardia.Cardiac conditions such as these can lead to thrombo-embolisms, heartfailure, and other complications in a patient. These treatmentapproaches provided herein can result in electrical isolation orblockage between various portions of cardiac tissue, optionally via thecreation of transmural ablations at selected locations on theendocardium. For example, methods and systems can be used to createscars that produce lines of electrical isolation, so as to inhibit orprevent electrical activity which may otherwise lead to or perpetuateatrial fibrillation, or so as to promote or maintain normal sinus rhythmin the patient. In some cases, these techniques can be used to formlesions at or near the pulmonary veins, the left atrial appendage, orthe mitral valve, for example. Techniques can be used to treat patientspresenting paroxysmal or intermittent atrial fibrillation, as well aspersistent or long-lasting persistent atrial fibrillation.

In some cases, systems and methods can involve placing an ablationassembly inside of the heart and adjacent to the endocardial tissue, andplacing a guiding assembly outside of the heart. The ablation assemblycan include an ablation element and a first attraction element, and theguiding assembly can include a second attraction element. In use, amagnetic attraction is present between the first and second attractionelements. The techniques typically involve forming an ablation on theendocardial tissue of the patient's heart with the ablation element ofthe ablation assembly.

The attraction elements can include magnets, magnetized or magnetizablematerials or objects, magnetically attractable materials or objects,materials or objects that produce a magnetic field, materials or objectsthat are attracted to or influenced by a magnetic field, and the like.Attraction elements can include devices such as magnets. For example, amagnetic member may include a combination of neodymium, iron, and boron.In some cases, a magnetic member may be nickel plated. In some cases, anattraction element can include a hard or permanent magnet that retainsits magnetization or magnetism. In some cases, an attraction element caninclude a soft or impermanent magnet that loses its memory of previousmagnetizations. Optionally, an attraction element can include anelectromagnet. In some cases, an attraction element can include amaterial which is not magnetized, but is attracted to a magnet, such asiron or a ferrous or ferromagnetic material. Hence, any of a variety ofmagnets, magnetizable or magnetized materials, or magneticallyattractable materials, may be used. According to some embodiments, anattraction element may include a nonferrous or paramagnetic materialsuch as magnesium or molybdenum.

By placing the ablation assembly and the guiding assembly in proximitywith each other, such that their respective attraction elements attract,a surgeon or operator can create lesions on the endocardium by using theguiding assembly to move the ablation element to various locations andforming ablations on the inside of the heart. In some cases, an ablationassembly can include a catheter with an ablation element on the distalportion of the catheter. Such methods are well suited for use intreating a patient with a beating heart, as the magnetic attraction orforce between the attraction elements can serve to maintain placement ofthe ablation element relative to the moving cardiac tissue.

Accordingly, in one embodiment, an operator can use the guiding elementsimilar to a pen or writing instrument, effectively drawing on theoutside of the heart while the ablation element forms a lesion on theendocardium using monopolar RF and a return path to one or moregrounding pads placed on the patient's skin. In an alternativeembodiment, the guiding element itself serves as an ablation element anda bipolar ablation is performed from the epicardial ablation element tothe endocardial ablation element. In some embodiments involving abipolar mode of ablation, a transmural ablation lesion may be moreassured because the heating pattern from the RF is more constrained andthe lesion grows from both the endocardium and the epicardium. In stillanother embodiment, the epicardial guide element includes a monopolarablation element, and the endocardial magnetic tip is not directlyinvolved in the ablation process. The magnetic tip provides a means tomove the epicardial ablation element or simply assures good contact ofthe ablation element to the epicardium. Hence, a guiding assembly can beplaced inside of the heart chamber, and can be magnetically attracted toan ablation assembly disposed on the exterior of the heart.Advantageously, such techniques may avoid or reduce the possibility ofcoagulating blood within a chamber of the heart, and hence provide abeneficial safety feature.

Turning now to the drawings, FIG. 1 illustrates an ablation treatmentsystem 100 according to embodiments of the present invention. Treatmentsystem 100 includes an ablation assembly 110 having an ablation element120 and a first attraction element 130. Treatment system 100 alsoincludes a guiding assembly 140 having a second attraction element 150.When in sufficiently close proximity, a magnetic attraction is presentbetween the first and second attraction elements. Ablation element 120may include an RF electrode, for example, and attraction element 130 mayinclude a magnet.

As illustrated in FIGS. 1A and 1B, lesions may be created by placingguiding assembly 140 a on or near the exterior of the heart and drawingor tracing a pattern proximate to the surface of the heart or cardiactissue 102 a as illustrated by guiding pattern 158 a. Due to attractionbetween first attraction element 130 a of ablation assembly 110 a andsecond attraction element 150 a of guiding assembly 140 a, acorresponding pattern can be traced on the interior surface of the heartor cardiac tissue 104 a, as illustrated by ablation pattern 160 a, and alesion can be created along the ablation pattern by ablation element 120a. Furthermore, the procedures may be performed while the patient'sheart is beating. Likewise, the procedures may be performed manually orwith the assistance of operative equipment. For example, as illustratedin FIG. 1A, in some cases a surgeon or operator may create the lesionsby hand 106 a using guiding assembly 140 a similar to a pen or otherwriting instrument to draw or trace a pattern on or near the exterior ofthe heart. Optionally, aspects of the procedure may be at leastpartially automated through the use of robotic or other equipment.Robotic or other equipment may be used to assist the surgeon or operatorin tracing or drawing the pattern or may be used solely to trace or drawthe pattern according to a set of instructions, optionally provided by acomputer. For example, FIG. 1B illustrates a robotic unit 108 boperating guiding assembly 140 b to trace or draw guiding pattern 158 bproximate to the surface of a heart. Consequently, ablation assembly 110b can trace a corresponding ablation pattern 160 b on the interior ofthe heart due to attraction between guiding assembly 140 b and ablationassembly 110 b. Embodiments of the present invention may encompass theuse of any of a variety of visualization guidance members to assist theoperator in performing a medical procedure, including endoscopicvisualization devices, fluoroscopy visualization devices, ultrasonicvisualization devices, and the like. Exemplary visualization members arediscussed in U.S. patent application Ser. No. 10/310,675 filed Dec. 4,2002, the content of which is incorporated herein by reference.Treatment systems may include mechanisms containing an attractionelement, an ablation element, and a temperature sensing element, asdiscussed elsewhere herein.

FIGS. 1A and 1B illustrate an endo-monopolar approach, whereby ablationenergy is provided by ablation element 120 a in a monopolar format onthe endocardial or interior surface of the heart tissue 104 a.Embodiments of the present invention also encompass epi-monopolarapproaches, as well as bipolar approaches. For example, FIGS. 1C and 1Dillustrate aspects of an epi-monopolar approach. Advantageously,epi-monopolar techniques may reduce the risk of stroke in a patientundergoing an ablation treatment, as the ablation energy is applied tothe exterior of the heart. There is less opportunity forablation-induced clots to form on the inside of the patient's heart andbe dispersed throughout the patient's circulation. As shown in FIG. 1C,lesions may be created by placing guiding assembly 140 c on or near theinterior of the heart and drawing or tracing a pattern proximate to thesurface of the heart or cardiac tissue 102 c as illustrated by guidingpattern 158 c. Due to attraction between first attraction element 130 cof ablation assembly 110 c and second attraction element 150 c ofguiding assembly 140 c, a corresponding pattern can be traced on theexterior surface of the heart or cardiac tissue 104 c, as illustrated byablation pattern 160 c, and a lesion can be created along the ablationpattern by ablation element 120 c. Furthermore, the procedures may beperformed while the patient's heart is beating. Likewise, the proceduresmay be performed manually or with the assistance of operative equipment.For example, as illustrated in FIG. 1C, in some cases a surgeon oroperator may create the lesions using a steerable catheter mechanism 106c that is coupled with or that includes guiding assembly 140 c to drawor trace a pattern on or near the interior of the heart. As depictedhere, a handle 108 c is coupled with steerable catheter mechanism 106 c,which can allow a surgeon or user to perform a robotically enhancedablation procedure. Optionally, aspects of the procedure may be at leastpartially automated through the use of robotic or other equipment.Robotic or other equipment may be used to assist the surgeon or operatorin tracing or drawing the pattern or may be used solely to trace or drawthe pattern according to a set of instructions, optionally provided by acomputer. For example, FIG. 1D illustrates a robotically aided catheteror remote control system 107 d having a guiding assembly 140 d inoperative association with a mechanically driveable system 108 d, whichis in operative association with a processor or computer controller 109d, which in turn is in operative association with a surgeon interface110 d. Such remote control systems or robotically assisted cathetermechanisms which are well suited for use in embodiments of the presentinvention are described in U.S. Pat. No. 7,214,230, the content of whichis incorporated herein by reference. Guiding assembly 140 d can be movedso as to trace or draw guiding pattern 158 d proximate to the interiorsurface of a heart. Consequently, ablation assembly 110 d can trace acorresponding ablation pattern 160 d on the exterior of the heart due toattraction between guiding assembly 140 d and ablation assembly 110 d.In an exemplary monopolar technique, a delivery electrode is used toadminister the ablative energy, and the return electrode is attached orcoupled with the patient's skin.

Any of a variety of robotic assisted techniques can be used tomanipulate a guiding assembly or catheter. For example, U.S. Pat. No.7,214,230, incorporated herein by reference, describes a remote controlflexible instrument system which can be used to robotically assist ordefine catheter or sheath manipulations. Embodiments of the presentinvention may encompass robotic assisted technologies such as thoseprovided by Hansen Medical, Inc. (Mountain View, Calif.).

Advantageously, bipolar techniques may reduce the risk of stroke in apatient undergoing an ablation treatment, as ablation energy is appliedto the exterior of the heart. There is less opportunity forablation-induced clots to form on the inside of the patient's heart andbe dispersed throughout the patient's circulation. In an exemplarybipolar system, a first electrode is disposed on one side of the tissue,for example on the epicardial surface of the heart, and a secondelectrode is disposed on the other side of the tissue, for example onthe endocardial surface of the heart. Current is drawn from one side tothe other; the sending electrode is located close to the returnelectrode, hence minimizing a spreading of the current. Current flowingthrough the tissue consequently heats the tissue from both sides, so asto efficiently create a transmural lesion. For example, application ofablative energy between a delivery electrode and a return electrode canheat the tissue to greater than about 50 degrees Celsius. In somebipolar embodiments, an active or guiding element is disposed on theexternal surface, and a passive or guidable element is disposed on theinternal surface. Optionally, an active or guiding element can bedisposed on the internal surface, and a passive or guidable element canbe disposed on the external surface. In a bipolar ablation, RF energytypically goes both ways, between the endocardium and the epicardium.

FIGS. 1E and 1F illustrate aspects of a bipolar approach according toembodiments of the present invention. As shown in FIG. 1E, lesions maybe created by placing guiding assembly or an outer bipolar ablationassembly 140 e on or near the exterior of the heart and drawing ortracing a pattern proximate to the surface of the heart or cardiactissue 102 e as illustrated by guiding pattern 158 e. As shown here,outer bipolar ablation assembly includes an attraction element 150 e andan ablation element 160 e. Due to attraction between first attractionelement 130 e of ablation assembly 110 e and second attraction element150 e of guiding assembly 140 e, a corresponding pattern can be tracedon the exterior surface of the heart or cardiac tissue 104 e, asillustrated by inner ablation pattern 160 e. Relatedly, guiding pattern158 e can also represent an outer ablation pattern. Hence, a transmuralablation can be created by the external ablation element 160 e and theinternal ablation element 120 e in a bipolar fashion. Furthermore, theprocedures may be performed while the patient's heart is beating.Likewise, the procedures may be performed manually or with theassistance of operative equipment. FIG. 1F illustrates a robotic unit108 f operating guiding assembly 140 b to trace or draw guiding pattern158 f proximate to the surface of a heart. Due to attraction between anexternal attraction element of the external assembly 140 f and aninternal attraction element of the internal assembly 110 f, acorresponding pattern can be traced on the interior surface of the heartor cardiac tissue, as illustrated by inner pattern 160 f. Relatedly,guiding pattern 158 f can also represent an outer ablation pattern.Hence, a transmural ablation can be created by the external ablationelement of the external assembly 140 f and the internal ablation elementof the internal assembly 110 f in a bipolar fashion.

FIGS. 1G and 1H illustrate aspects of other bipolar approaches. As shownin FIG. 1G, lesions may be created by placing guiding assembly 140 g onor near the interior of the heart and drawing or tracing a patternproximate to the surface of the heart or cardiac tissue 102 g asillustrated by guiding pattern 158 g. Due to attraction between firstattraction element 130 g of ablation assembly 110 g and secondattraction element 150 g of guiding assembly 140 g, a correspondingpattern can be traced on the exterior surface of the heart or cardiactissue 104 g, as illustrated by external ablation pattern 160 g.Relatedly, guiding pattern 158 g can also represent an inner ablationpattern. Hence, a transmural ablation can be created by the externalablation element 120 g and the internal ablation element 160 g in abipolar fashion. As shown here, external ablation element 120 g orinternal ablation element 160 g may include a metallic ring, band, orsleeve. Optionally, the ablation element or electrode can encircle orsurround an attraction mechanism. In some cases a surgeon or operatormay create the lesions using a steerable catheter mechanism 106 g thatis coupled with or that includes guiding assembly 140 g to draw or tracea pattern on or near the interior of the heart. As depicted here, ahandle 108 g is coupled with steerable catheter mechanism 106 g, whichcan allow a surgeon or user to perform a robotically enhanced ablationprocedure. Optionally, aspects of the procedure may be at leastpartially automated through the use of robotic or other equipment.Robotic or other equipment may be used to assist the surgeon or operatorin tracing or drawing the pattern or may be used solely to trace or drawthe pattern according to a set of instructions, optionally provided by acomputer. For example, FIG. 1H illustrates a robotically aided catheteror remote control system 107 h having a guiding assembly 140 h inoperative association with a mechanically driveable system 108 h, whichis in operative association with a processor or computer controller 109h, which in turn is in operative association with a surgeon interface110 h. Such remote control systems or robotically assisted cathetermechanisms which are well suited for use in embodiments of the presentinvention are described in U.S. Pat. No. 7,214,230, the content of whichis incorporated herein by reference. Guiding assembly 140 h can be movedso as to trace or draw guiding pattern 158 h proximate to the interiorsurface of a heart. Consequently, outer ablation assembly 110 h cantrace a corresponding external ablation pattern 160 h on the exterior ofthe heart due to attraction between guiding assembly 140 d and ablationassembly 110 h. Relatedly, guiding pattern 158 h can also represent aninner ablation pattern. Hence, a transmural ablation can be created bythe external ablation element of external ablation assembly 110 h andthe internal ablation element of internal ablation assembly 140 h in abipolar fashion.

As depicted in embodiments provided in FIGS. 1A-1H, treatment systemsmay include a driving or leading element disposed either externally atthe epicardial surface, or internally at the endocardial surface.Similarly, a passive or following element can be disposed eitherinternally at the endocardial surface, or externally at the epicardialsurface. Embodiments of the present invention encompass systems whichprovide a monopolar ablation element at the endocardial surface, asdepicted in FIG. 1A. Embodiments of the present invention also encompasssystems which provide a monopolar ablation element at the epicardialsurface, as depicted in FIG. 1C. Embodiments of the present inventionfurther encompass systems which provide a bipolar ablation elements atthe epicardial and endocardial surfaces, as depicted in FIG. 1E. Any ofthe configurations described here are well suited for use with theraceway or tracking systems described in FIGS. 5A-6D. What is more, anyof the embodiments depicted here can incorporate power deliverymodalities wherein the power delivered is based on temperature feedbackcontrol of power.

In a bipolar ablation procedure, it may be desirable to performtemperature sensing at or near the epicardium when determining how muchpower is to be delivered for the ablation. For example, temperaturecontrol can be modulated based on temperatures sensed at or near anepicardial electrode. In general, an electrode disposed at or near theendocardium will be exposed to flowing blood in the heart and thereforewill be cooler than an electrode disposed at or near the epicardium. Itmay be desirable to control the ablation power based on the tissueexhibiting the higher temperature, which is most often the epicardium.Typically, during an ablation, heat flows into the tissue being ablated,more so than into the surrounding environment.

According to some embodiments, control of ablative power administrationis based on epicardial temperature sensing. In some cases, the size orsurface area of an epicardial electrode is larger than the size orsurface area of an endocardial electrode, and temperature sensing can beperformed at or near the endocardial surface. For example, the surfacearea of the epicardial electrode may be twice the surface area of theendocardial electrode. In some cases, it may be desirable to place atemperature sensor on the smaller of two differently sized electrodes,as the current density is likely to be greater on a smaller electrodehence providing a higher temperature. It may be desirable to maintainthe temperature at or near the endocardial surface below a selectedvalue (e.g. between about 50 and 60 degrees Celsius) so as to minimizethe possibility of clot formation, while providing sufficient heat toablate the tissue. Relatedly, it may be desirable to control theablative energy administered based on the greater of the epicardialtemperature and the endocardial temperature. Optionally, it is possibleto predetermine which of the epicardial or endocardial surfacetemperatures will be greater during a treatment, and subsequentlycontrol the power administered during the treatment based on the surfacehaving the greater predetermined temperature. In some cases, it ispossible to perform temperature sensing at or near both the epicardialand endocardial surfaces. In some cases, it is possible to predict orpredetermine the temperature at or near the epicardial surface based onthe sensed temperature at or near the endocardial surface. In somecases, it is possible to predict or predetermine the temperature at ornear the endocardial surface based on the sensed temperature at or nearthe epicardial surface. According to some embodiments, two or moretemperature sensors are used to monitor temperatures of the epicardialand endocardial surfaces, and ablative power is administered so as tomaintain a selected temperature differential between the epicardial andendocardial surfaces. For example, techniques may involve the modulationor administration of power to a bipolar ablation device so thatepicardial tissue temperature does not exceed an amount that is about 10degrees Celsius higher than the endocardial tissue temperature.Optionally, techniques may involve the modulation or administration ofpower to a bipolar ablation device so that epicardial tissue temperatureis maintained at a temperature that is about 10 degrees Celsius higherthan the endocardial tissue temperature. In some bipolar embodiments,control of ablative power is based on the epicardial temperature, theendocardial temperature, or both.

In addition to utilizing radiofrequency (RF) ablation modalities,embodiments of the present invention can incorporate any of a variety ofablation techniques, including without limitation microwave, laserenergy, high intensity focused ultrasound (HIFU), and other heatingtechnologies. Exemplary embodiments which include magnetic navigationand temperature sensing for RF ablation mechanisms are depicted at, forexample, FIG. 11 , as discussed elsewhere herein.

Although in many instances it is desirable to position an endocardialablation or guiding element via an arterial access route, such asthrough the femoral artery, it is understood that in some instances anendocardial ablation or guiding element can be directly inserted intothe left atrium, for example during a medical procedure that involvesopening up the left atrium itself. Bipolar ablation modalities describedherein are well suited for such procedures.

FIGS. 2-4 illustrate the use of treatment systems having ablationassemblies and guiding assemblies in accordance with the embodiments ofthe present invention. The figures further illustrate several operativeprocedures that may be employed to create a lesion formation on theendocardial tissue of the heart. A lesion formation, which may also bereferred to as a lesion, may include the creation of a single lesion, aseries of associated lesions, multiple lesions such as a pair ofparallel lesions, a set of lesions, a series of lesions, and the like.Lesions can be formed in accordance with any of the procedures describedherein. In some cases, lesions may be partially or fully transmural. Forexample, a lesion may extend partially through, or fully through, thethickness of a tissue or organ wall. The term lesion may refer to thevolume of tissue rendered permanently electrically unresponsive, mostcommonly due to irreversible thermal injury. Eventually the affectedtissue becomes scar tissue. Because of the destructive change in thetissue, the lesion blocks the transmission of tissue excitation forcingthe conduction pathway of the excitation waveform to either go aroundthe lesion or to terminate at the lesion site.

In some cases, the treatment system may be used to create a singlelesion that substantially encloses or encircles all the pulmonary veinsor multiple lesions that each enclose or encircle one or more of thepulmonary veins. Furthermore, additional lesions may be created thatconcern other areas of the heart such as the left atrial appendage andthe mitral valve.

FIG. 2 illustrates treatment system 200 in use to create a lesion thatsubstantially encloses or encircles the ostia of the right and leftsuperior pulmonary vein, 275 and 280 respectively, and the ostia of theright and left inferior pulmonary veins, 285 and 290 respectively.Treatment system 200 can be used to create an additional lesion stemmingfrom a lesion near the pulmonary veins and extending toward the leftatrial appendage orifice 295. A lesion substantially enclosing an ostiumof a pulmonary vein may be created by placing guiding assembly 240 at ornear one of a pulmonary vein and tracing or drawing a loop around theperiphery of one or more pulmonary veins. As previously described, dueto an attraction between guiding assembly 240 and ablation assembly 210,a corresponding pattern can be traced on the interior of the heart, asillustrated by ablation pattern 260, and a lesion can be created alongablation pattern 260 by an ablation element 230 of ablation assembly210. Typically, ablation assembly 210 is advanced through the atrialseptum, when traversing from the right atrium to the left atrium.

In a similar manner an additional lesion may be created that stems froma lesion near or enclosing a pulmonary vein ostium and that extendstoward left atrial appendage orifice 295 by placing guiding assembly 240at or near the left inferior pulmonary vein 290, for example, andtracing or drawing a path 270 toward left atrial appendage orifice 295.As previously described, a corresponding pattern is traced on theinterior of the heart, as illustrated by ablation pattern 270, and alesion can be created along the ablation pattern. In some cases, whenthe lesion is at or in close proximity with left atrial appendageorifice 295, it may be made to fork or “T.” For example, the lesion maybe made to fork or “T” along ablation pattern 265.

In some cases, it may be difficult to ablate between the right pulmonaryveins, or between the left pulmonary veins. Hence, it may be desirableto ablate around the right pulmonary veins collectively, or around theleft pulmonary veins collectively, or both. The left atrial appendagemay be part of a re-entrant circuit, and a treatment can involveelectrically isolating the left atrial appendage by ablating it, bysewing it shut, or by severing it.

FIG. 3 illustrates use of treatment system 300 to create multiplelesions enclosing the pulmonary veins and about other areas of theheart. For example, a lesion can enclose or encircle the ostia of theright and left superior pulmonary veins, 375 and 380 respectively.Similarly, a lesion can enclose or encircle the ostia of the right andleft inferior pulmonary veins, 385 and 390 respectively. Optionally, alesion may enclose or encircle a left atrial appendage orifice 395. Alesion may also extend toward the mitral valve 368.

In accordance with procedures described herein, a lesion substantiallyenclosing the right superior and inferior pulmonary veins, 375 and 385respectively, may be created by positioning guiding assembly 340 at ornear one of the right pulmonary veins and tracing or drawing a looparound the periphery of both the right superior and inferior pulmonaryveins such that corresponding ablation pattern 360 is traced on theinterior of the heart by ablation assembly 310. In a similar manner, alesion substantially enclosing the left superior and inferior pulmonaryveins, 380 and 390 respectively, may be created by placing guidingassembly 340 at or near one of the left pulmonary veins and tracing ordrawing a loop around the periphery of both the left superior andinferior pulmonary veins such that corresponding ablation pattern 365 istraced on the interior of the heart by ablation assembly 310. Theseparate lesions enclosing each of the right and left pulmonary veinsmay then be associated or connected by placing the guiding assembly nearone of the lesions and tracing or drawing a path toward the otherlesion, thereby connecting both lesions. For example, the associatinglesion may be created along ablation pattern 362.

Furthermore, in accordance with procedures described herein, a lesionsubstantially enclosing the left atrial appendage orifice 395 may becreated and associated with the lesion enclosing the inferior pulmonaryveins by tracing or drawing a loop and path that correspond withablation patterns 370 and 372 respectively. Likewise, an additionallesion may be created that stems from a lesion that encloses either ofthe inferior pulmonary veins and that extends substantially to themitral valve 368 by placing the guiding assembly at or near the lesionenclosing the inferior pulmonary vein and tracing or drawing a pathtoward the mitral valve 368 that corresponds with ablation pattern 374.This lesion may be made to fork or “T” along ablation pattern 374 whenthe lesion is at or in close proximity to the mitral valve 368. Ablationpattern 374 may extend to connect with ablation pattern 360 whichencircles the right pulmonary veins.

In accordance with procedures described herein, a lesion substantiallyenclosing the right and left superior pulmonary veins, 375 and 380respectively, may be created by positioning guiding assembly 340 at ornear one of the superior pulmonary veins and tracing or drawing a looparound the periphery of both the right and left superior pulmonary veinssuch that corresponding ablation pattern is traced on the interior ofthe heart by ablation assembly 310. In a similar manner, a lesionsubstantially enclosing the right and left inferior pulmonary veins, 385and 390 respectively, may be created by placing guiding assembly 340 ator near one of the inferior pulmonary veins and tracing or drawing aloop around the periphery of both the right and left inferior pulmonaryveins such that corresponding ablation pattern is traced on the interiorof the heart by ablation assembly 310. The separate lesions enclosingeach of the superior and inferior pulmonary veins may then be associatedor connected by placing the guiding assembly near one of the lesions andtracing or drawing a path toward the other lesion, thereby connectingboth lesions.

A pericardial reflection is typically present between the right and leftpulmonary veins. The process of ablating between the right and leftpulmonary veins, for example as illustrated by lesion or ablationpattern 362, may involve a concomitant dissection of the pericardialreflection between the right and left pulmonary veins at or near theepicardium. The pericardial reflection presents a ridge or line ofattachment between the right and left pulmonary veins. For example, FIG.3A illustrates a pericardial reflection 310 between the rightpericardial veins 320 and the left pericardial veins 330.

When navigating a treatment system, in some cases it may be desirable toavoid placing the system in close proximity to the circumflex artery, orto avoid generating undue temperature conditions near the circumflexartery. Endocardial techniques may be less likely to generate suchtemperatures as compared with bipolar or epicardial techniques.Similarly, it may be desirable to avoid placing an ablation elementwithin the interior of a pulmonary vein. Embodiments of the presentinvention, including epicardial magnetic techniques, are well suited forproviding techniques that involve a reduced or minimized probability ofplacing an ablation element within the interior of a pulmonary vein, orwithin the interior of the left atrial appendage orifice.

The aortic valve has three bulging components, or cusps. One cuspcontains a left artery and another cusp contains a right coronaryartery. A third cusp does not contain any coronaries, and is whereaortic valve is transitioned and attached to the aorta. This area isalso known as the fibrous trigone, a fibrous ring shared by both theaorta and the mitral valve. Embodiments of the present invention involveablating or creating a lesion at or near the trigone. For example, aconnecting lesion can be formed at the trigone on the left atrium, to alocation that is near both the aortic valve and the mitral valve.Epicardial techniques are well suited for creating such lesions. With anepicardial ablation approach, using a system with an ablation element atthe epicardial surface, it is possible to form a lesion to the mitralvalve annulus. Such lesions can help to reduce atrial flutter.

FIG. 4 illustrates use of treatment system 400 to create a lesionsubstantially enclosing the pulmonary vein ostia and a lesion extendingtoward the mitral valve. In accordance with procedure described herein,a lesion substantially enclosing ostia of pulmonary veins, 475, 480,485, and 490 respectively, may be created by positioning guidingassembly 440 at or near one of the pulmonary veins and tracing ordrawing a loop around the periphery of the superior and inferiorpulmonary veins so that corresponding ablation pattern 460 is traced onthe interior of the heart and a lesion is created along the ablationpattern. In a similar manner, a lesion may be created stemming from thelesion enclosing the pulmonary veins and extending towards the mitralvalve 468 by placing guiding assembly 440 at or near the lesionenclosing the pulmonary veins and tracing or drawing a path toward themitral valve 468 that corresponds with ablation pattern 465. In somecases, a lesion extending toward mitral valve 468 may be positionedclosely to the right inferior pulmonary vein and extend substantially tothe mitral valve.

According to embodiments of the present invention, a treatment systemcan be introduced into the patient's body and placed at or near theheart tissue using any of a variety of insertion techniques. Forexample, methods for placing or positioning devices at, near, into,between, or among certain anatomical features within the patient's body,for example within the patient's thoracic cavity, are described in U.S.patent application Ser. Nos. 12/124,743 and 12/124,766, filed May 21,2008, Ser. No. 12/339,331 filed Dec. 19, 2008, and 61/051,975 filed May9, 2008. The entire disclosure of each of these references isincorporated herein by reference for all purposes. Exemplary treatmentsystem positioning techniques may involve navigation at or near thetransverse and oblique sinuses, or breaking through the pericardialreflection where pericardium attaches to heart, or passing between oraround the right and left pulmonary veins, or any combination thereof.Certain approaches can entail dissection of attachments that occur nearthe transition between the right atrium and the left atrium.

Guiding assemblies can be maneuvered about the surface of heart orcardiac tissue by guidance systems which are well suited for creatingcertain lesion configurations, such as box lesions. FIGS. 5A-5F depictaspects of guidance systems according to embodiments of the presentinvention. It is noted that similar device positioning features aredescribed with reference to ablation systems disclosed in previouslyincorporated U.S. Patent Application No. 60/939,201 filed May 21, 2007,U.S. patent application Ser. Nos. 12/124,743 and 12/124,766 filed May21, 2008. Any of the positioning or placement techniques described inthese applications can be similarly used for maneuvering guidingassemblies relative to patient tissue. For example, FIG. 5A shows aguiding system 500 having a distal end 510 and a belt loop 520. Further,the guiding system includes a guiding assembly 530. Distal end 510 ofsystem 500 is disposed through belt loop 520. FIG. 5B shows across-section view of a portion A-A of FIG. 5A. As depicted in FIG. 5C,guidance system 500 can be disposed about a large atria. Similarly, asdepicted in FIG. 5D, guidance system 500 can be disposed about a smallatria. According to FIG. 5E, guidance system 500 can have a receivingslot 540 adapted to receive guiding assembly 530. According to FIG. 5F,guidance system 500 f can include an ablation element 533 f.

With a more detailed reference now to FIG. 5A, guidance system 500includes a flexible guiding member 580, an encircling mechanism or catch520 such as a belt loop, a hook, a closable clasp, or the like, and aflexible stabilizer member or bracing 560 having a distal end 510, aproximal end 570, and a recessed receiving slot or receptacle 540. Asdepicted here, flexible guiding member 580 may be attached with orinclude a guiding assembly 530, which can include an attraction elementsuch as a magnet. The combination of the guiding member 580 (or theguiding assembly 530) and the stabilizer member 560 can collectively bereferred to as the guidance system 500. In use, an operator may treat apatient by wrapping a loop structure 511 of the guidance system 500around one or more pulmonary veins (PV) of a patient. This may involvepassing flexible bracing distal end 510 circumferentially around thetissue as indicated arrow B, and through belt loop 520 as indicated byarrow C. The operator may expand or contract guidance system 500 bymanipulating the flexible stabilizer member distal end 510. Movingdistal end 510 in direction D results in contraction of loop structure511 of guidance system 500 in a cinching fashion. Moving distal end 510in direction E results in expansion of loop structure 511 of guidancesystem 500. Stabilizer member 560 may be made of or include any suitableflexible material, such as a silicone, Teflon, polyurethane,polyethylene, another suitable polymer, or combination of polymers orthe like.

In some embodiments of use, a surgeon or operator can pass stabilizermember distal end 510 through catch 520, and expand or contract guidancesystem 500 by manipulating the flexible bracing proximal end 570. Movingproximal end 570 in direction F results in contraction of loop structure511 of guidance system 500 in a cinching fashion. Moving proximal end570 in direction G results in expansion of loop structure 511 ofguidance system 500. FIG. 5B depicts a cross-section portion A-A ofguidance system 500 as shown in FIG. 5A. As shown here, receiving slot540 is located adjacent to guiding member 580. In some cases, receivingslot 540 might be located on either side of guiding member 580.Receiving slot 540 is adapted to receive a distal section of guidingmember 580 or guiding assembly 530.

As shown in FIG. 5C, a surgeon or operator can detach or separateguiding assembly 530 from stabilizer member 560 and insert portion 530into receiving slot 540, for example by grasping and manipulating theportion 530 with a positioning device 550. In some cases, a distalportion of the stabilizer member can be inserted through catch 520. Apositioning device such as a forceps or grasper can be introduced intothe patient via a minimally invasive incision or port. For example, astab device having a cylindrical opening can present a cutting pointthat expands as it is introduced into the patient's tissue. In somecases, a port may include a valve. Optionally, a fluid or gas such acarbon dioxide can be introduced via the port, and can effectivelydisplace or push away lung tissue, thereby providing an operating spacewithin the patient's chest. Instruments, including imaging devices, maybe inserted and removed via an incision or port. Positioning device 550may be used by the operator to detach guiding assembly 530 from flexiblebracing 560 and to insert the detached section of section 530 intoreceiving slot 540 so that guiding member 580 approximately encirclestissue of a heart.

In some cases, bracing 560 can be aligned such that the operator cansimply advance guiding member 580 or guiding assembly 530 along bracing560, without additional assistance from positioning device 550, suchthat the guiding assembly tracks along the bracing, extending from adistal portion of the bracing and returning to a more proximal portionof the bracing.

As depicted in FIG. 5A, for example, guidance system 500 can beconfigured so as to substantially enclose or encircle all four pulmonaryveins (PV). By translating guiding assembly 530 along stabilizer member560, the operator can create a box lesion around the pulmonary veinswith an ablation element that is disposed within the interior of theheart. Hence, an operator can administer ablative energy through anablation member to produce a circular or closed ablation pattern orlesion on the patient tissue. The ablation element can be used toproduce any of a variety of circular, elliptical, or closed ablationpatterns or lesions from the interior of the large atria. As shown inFIG. 5D, guidance system 500 may be used to help produce an ablationpattern or lesion on a small atria. Because the atria is smaller, alonger section of flexible stabilizer member 560 may be moved thoughcatch 520 in order to snugly fit the guiding assembly around the atria.This may involve a longer section of distal guiding assembly 530 beinginserted into receiving slot 540. By administering ablative energythrough an ablation system disposed within the interior of the heart, anoperator can use guidance system 500 to help produce any of a variety ofcircular, elliptical, or closed ablation patterns or lesion from theinterior of the small atria.

FIG. 5E provides a partial view of guidance system 500. Catch 520 isshown without the distal end of flexible bracing 510 inserted therein.In this embodiment, guiding member section 580 is partial recessed ordisposed within a receptacle or slot 550 of flexible bracing 560.Receiving slot 540 is adapted to receive a distal section of guidingassembly 530 after the guiding assembly is advanced distally along slot550 in the direction indicated by arrow A. As depicted here, a distalportion of guiding assembly 530 can include an attraction element 532such as a magnet. Guiding assembly 530 can be advanced distally orretracted proximally as indicated by arrow B. In some embodiments, suchtranslational motion can be effected with any of a variety of motorizedor mechanized elements, such as gears, drives, rack and pinionassemblies, worm gear assemblies, and the like. As depicted in FIG. 5E,guiding assembly 530 can be coupled with a drive mechanism 590, whichprovides translational movement to guiding assembly 530 or guidingmember 580. Guiding assembly 530 can present any of a variety ofattraction element configurations. In some cases, an attraction elementmay include a flexible material, so as to facilitate good contactbetween the guiding assembly and the surface contours of the patienttissue or organ.

FIG. 5F provides a partial view of guidance or ablation system 500 f.Catch 520 f is shown without the distal end of flexible bracing 510 finserted therein. In this embodiment, guiding member section 580 f ispartial recessed or disposed within a receptacle or slot 550 f offlexible bracing 560 f. Receiving slot 540 f is adapted to receive adistal section of guiding assembly 530 f after the guiding assembly isadvanced distally along slot 550 f in the direction indicated by arrowA. As depicted here, a distal portion of guiding assembly 530 f caninclude an attraction element 532 f such as a magnet, and an ablationelement 533 f such as an RF electrode. Guiding assembly 530 f can beadvanced distally or retracted proximally as indicated by arrow B. Insome embodiments, such translational motion can be effected with any ofa variety of motorized or mechanized elements, such as gears, drives,rack and pinion assemblies, worm gear assemblies, and the like. Asdepicted in FIG. 5F, guiding assembly 530 f can be coupled with a drivemechanism 590 f, which provides translational movement to guidingassembly 530 f or guiding member 580 f. Guiding assembly 530 f canpresent any of a variety of attraction element configurations. In somecases, an attraction element may include a flexible material, so as tofacilitate good contact between the guiding assembly and the surfacecontours of the patient tissue or organ.

Referring now to FIG. 6A, in some embodiments an guidance system 600includes a flexible device which includes an encircling mechanism 605having a breakaway tip 630, a slit 650, and a living hinge 680. Guidancesystem 600 also includes a guiding member 620 in operative associationwith a stabilizer member 610. The stabilizer member can operate as araceway or track, and guiding member 620 can translate in a forward orbackward direction within the raceway. The raceway can house an ablationelement or a navigation or guiding element. As shown in FIG. 6B,guidance system 600 can be extended around a large atrium of a patient.In use, a surgeon can insert a stiffening probe 695 into a distal end612 of stabilizer member 610. By manipulating distal end 612 ofstabilizer member 610, or by adjusting proximal end 614 of stabilizermember 610 relative to encircling mechanism 605, an operator canactivate hinge 680 and move breakaway tip 630 toward the atrium. Thispushing action causes breakaway tip 630 to move away from a portion 660of the stabilizer member that is located on the opposing side of slit650. Hence, breakaway tip 630 can act as an extension of the raceway fora guiding member, or for an ablation member, allowing such a guidingmember or ablation member to travel in a circular path around the hearttissue. In some cases, slit 650 extends about half way through a crosssection of the stabilizer member. In a manner similar to that describedabove with reference to FIGS. 5A-5F, an operator can transmit ablativeenergy through an ablation member disposed within the heart chamber, soas to produce an approximately circular, elliptical, or closed ablationpattern or lesion. As shown in FIG. 6C, an operator can use guidancesystem 600 to help apply ablative energy to a small atrium, in a similarfashion. Stiffening probe 695 can be pushed farther toward the heart, inthe direction indicated by arrow A, which can cause the expansion of awider angle defined by slit 650, as hinge 680 opens further andbreakaway tip 630 moves more distally along guiding member 620, asindicated by arrow B. Hence, breakaway tip 630 can move closer to theatrium, and guiding member 620 can snugly fit against the atrium. Insome cases, it may be desirable to move proximal end 614 of thestabilizer member in the direction indicated by arrow C, which can alsoeffectively move breakaway tip 630 more distally along guiding member620, as indicated by arrow B. Optionally, the surgeon or operator canmove distal portion 612 in the direction indicated by arrow D, orproximal portion 614 in the direction indicated by arrow E, so as tomove the breakaway tip more proximally along the guiding member, asindicated by arrow F. In this way, by manipulating aspects of the systemsuch as the distal end or the proximal end of a stabilizer member, anoperator can adjust the size of a loop structure 611 provided by theguidance system. In some instances, the guiding member may be adjustedto contact epicardial tissue directly adjacent to the base or ostia ofone or more pulmonary veins. In some instances, the ablation member maybe adjusted so that a gap exists between the ablation member and thepulmonary veins.

FIG. 6D provides a close-up view of encircling mechanism 605 of theablation system, which includes breakaway tip 630, slit 650, and livinghinge 680. In some embodiments, guiding member 620 can extend to thedistal end or nearly to the distal end of breakaway tip 630. Bymanipulating aspects of the system, such the distal end or the proximalend of a guiding assembly, an operator can adjust an angle a of definedby slit 650. Hence, it is possible to conform the guiding member with acontour presented by a patient tissue. When the guiding member is placedat or near the tissue, ablative energy can be transmitted through anablation member disposed on the other side of the tissue, thus ablatingat least a portion of the tissue to form one or more lesions. Asdepicted in FIG. 6D, guiding assembly 620 may include an attractionelement 622 such as a magnet. Guiding assembly 620 may be advanceddistally or retracted proximally as indicated by arrow G. In someembodiments, such translational motion can be effected with any of avariety of motorized or mechanized elements, such as gears, drives, rackand pinion assemblies, worm gear assemblies, and the like. For example,as depicted in FIG. 6C, guiding assembly 620 can be coupled with a drivemechanism 690. FIG. 6E illustrates a guiding assembly 620 e according toembodiments of the present invention. The guiding assembly includes anattraction element 622 e such as a magnet, and an ablation element 623 esuch as an RF electrode. Guiding assembly 620 e may be advanced distallyor retracted proximally as indicated by arrow G. In some embodiments,such translational motion can be effected with any of a variety ofmotorized or mechanized elements, such as gears, drives, rack and pinionassemblies, worm gear assemblies, and the like.

With reference to FIGS. 5A-5F and 6A-6E, for example, a guiding assemblyor catheter with a magnetic tip can be inserted into or through thestabilizer member, or the guiding assembly can be otherwise constrainedto be captured within or translated along one or more elements of theguidance system. The guiding assembly, with the attraction elements, canbe advanced or withdrawn either manually or removably connected to amotorized drive shaft that advances or withdraws the guiding assemblyautomatically at a predetermined rate. In some embodiments, RF power toan endocardial ablation element can be temperature feedback controlledto maintain a predetermined temperature set point, for example in therange of 50° C. to 70° C. Alternatively, RF power applied to theendocardial ablation device could be held constant and the translationrate can be feedback controlled to maintain the temperature of theendocardial ablation device at a predefined temperature, for example 60°C. In this translation mode, the ablation device can be driven over aparticular point on the endocardium one or more times. One way to createa transmural ablation pattern efficiently is to return to a given spotevery 5-15 seconds, since thermal conduction times can be relativelyslow, whereas localized tissue heating tends to be at least 10-foldfaster than the times required for heat to conduct from hotter tissuesto cooler spots. The stabilizer member bracing, or epicardial tubularguide tube, can be made from a material with very low magneticsusceptibility, for example a biocompatible plastic material. Hence,components of the system can be selected so as not to interfere with theattractive or magnetic properties of the attraction elements. Exemplarymaterials may include polyurethane or Teflon. In some cases, the tubediameter can be within a range from about 3 mm to about 6 mm, and thewall thickness can be about 1 mm or less, so as to enable adequatemagnetic attractive force between the endocardial magnetic element andthe moveable magnetic catheter tip contained within the guide tube.

The embodiments depicted in FIGS. 5A-5F and 6A-6E are well suited formaintaining an attraction element such as a magnet close to the surfaceof the heart. Proximity between attraction elements is often desirable.For example, magnetic field strength can diminish as a function of thedistance between magnets. In some embodiments, an attraction element ismaintained or housed within a thin tubing or member, which can hold theattraction element in place. Optionally, this housing member can beabout 0.5 mm or less in thickness. The housing member or membrane caninclude a biocompatible material, such as Teflon, polyurethane, oranother plastic.

In some cases, the guiding assembly or introducer system can be used tomove an attraction element. In some cases, the guiding assembly can beused to move an assembly that includes an attraction element, anelectrode or ablation element, or a temperature sensor, or anycombination thereof. Attraction elements can include devices such asmagnets. For example, a magnetic member may include a combination ofneodymium, iron, and boron. In some cases, a magnetic member may benickel plated.

Optionally, the internal diameter of the tubular guide can be about 0.5mm larger than the outer diameter of the moveable magnetic catheter toenable free and easy translation of the magnetic tip within the guidetube. Hence, embodiments of the present invention encompass systems thatinclude a tube structure that can be routed around certain structures ofthe epicardium in specific formations. A tube structure can contain orhouse a motorized magnet within it such that the moving magnet withinthe tube moves from one end of the tube toward another following theanatomical path of which the tube was placed while moving a magneticallyattracted catheter inside the heart along with it.

In some embodiments, guiding assemblies can be positioned or maneuveredrelative to patient tissue using introducer techniques such as thosedescribed in previously incorporated U.S. Patent Application No.61/015,472 filed Dec. 20, 2007.

Embodiments of the present invention encompass techniques forcontrolling temperature, and for controlling power based on temperaturesensing. Examples of such approaches are described in U.S. Pat. No.6,245,065, which discusses temperature control of ablation. The entirecontents of this patent are incorporated herein by reference.

Embodiments of the present invention encompass techniques for placingablation assemblies or guiding assemblies into chambers of the heart.FIGS. 7, 5A, 5B, and 9 illustrate how an endocardial magnetic ablationelement can be advanced into the left atrium. As depicted in FIG. 7 , asteerable catheter 705 can be used to guide an outer sheath 710 into adesired position within the patient's heart 750. The outer guide sheath710 includes an interior bore that receives the steerable catheter body.The physician can slide the outer guide sheath 710 along the steerablecatheter body. A handle 712 of the outer sheath 710 may include aconventional hemostatic valve 714 that blocks the outflow of blood andother fluids. The valve 714 may take the form of a resilient slottedmembrane or a manually operated shutter valve arrangement, for example.Valves 714 and 716 can provide an effective hemostatic system, and thusallow performance of a procedure in a clean and relatively bloodlessmanner. In use, the steerable catheter body enters the bore of the guidesheath 710 through the valve 714. The handle 712 of the outer sheath 710also may include a flushing port 718 for the introduction of ananticoagulant or saline into the interior bore. The physician canadvance the catheter body and the outer guide sheath 710 togetherthrough the femoral vein. The physician may retain the sheath handle 712near the catheter handle to keep the catheter tip outside the distal endof the outer sheath 710. In this way, the physician can operate asteering lever to remotely point and steer the distal end of thecatheter body while jointly advancing the catheter body through thefemoral vein. The physician can observe the progress of the catheterbody using fluoroscopic or ultrasound imaging, or the like. The outersheath 710 can include a radio-opaque compound, such as barium, for thispurpose. The physician can locate the distal end of the catheter body inthe right atrium 720, and the outer sheath handle 712 can be slidforward along the catheter body, away from the handle and toward theintroducer 722. The catheter body can direct the guide sheath 710 fullyinto the right atrium 720. Holding the handle 712 of the outer sheath710, the physician can withdraw the steerable catheter body from theouter guide sheath 710. Thus, the delivery system 730 can be deployed inthe condition generally shown in FIG. 7 .

The system 730 creates a passageway that leads through the femoral veindirectly into the right atrium 720. The delivery system 730 providesthis access without an invasive open heart surgical procedure.Alternatively, the outer guide sheath 710 can itself be preshaped with amemory. The memory may assume a prescribed curvature for access to theright or left atrium 720 or 721 through venous access, without need fora steerable catheter. To assist passage through the atrial septum 740,the delivery system 730 may include a transeptal sheath assembly. Thedelivery system 730 can guide the sheath assembly into the right atrium720 and through the atrial septum 740 to open access to the left atrium721. The delivery system 730 further includes an ablation probe to carrya selected ablating element.

As depicted in FIG. 5A, a physician may deploy a visualization device810, such as an ultrasonic viewing probe, through the femoral vein intothe right atrium 814, either within or outside a guide sheath.Alternatively, fluoroscopy or other visualization modalities could beused. The physician can operate the visualization device to observeother system elements disposed within the heart. As shown in FIG. 5B,the physician or operator can advance the transeptal sheath assembly 830through the guide sheath 840 into the atrial septum 842. The viewingprobe can be used to monitor the position of the guide sheath 840 andthe advancement of the transeptal sheath assembly 830 toward the atrialseptum 842. The transeptal sheath assembly 830 includes a cutting edgeor dilator 832 that carries a sharpened lead wire 834. As the physicianadvances the transeptal sheath assembly 830, the lead wire 834 forms aninitial opening in the septum 842. The dilator 832 enters this opening,enlarging it and punching through to the left atrium 844. Thistranseptal approach is well suited for left atrium access procedures.The physician can slide the guide sheath 840 along the transeptal sheathassembly 830 and into the left atrium 844. The physician can thenwithdraw the transeptal sheath assembly 830 from the guide sheath 840,such that the guide sheath 840 forms a path through the femoral vein andright atrium into the left atrium 844.

As depicted in FIG. 9 , the physician or operator can introduce anablation assembly 850 through guide sheath guide sheath 840. Thus, theablation assembly 850 can be placed inside of the heart and adjacent tothe endocardial tissue. A guiding assembly 860 can be placed outside ofthe heart. The operator can use magnetic attraction present between aguiding assembly magnet and an ablation assembly magnet to help guidethe ablation assembly so as to form an ablation or desired pattern oflesions on the endocardial tissue of the patient's heart with anablation element of the ablation assembly. Upon establishing the desiredlesion pattern, the physician can withdraw the ablation assembly 850from the guide sheath 840, and then withdraw the guide sheath 840 fromthe heart and femoral vein. Relatedly, it is understood that transeptalintroduction can be achieved by inserting an introducer or sheath withan internal dilator through the femoral or jugular vein and into theinterior of the right atrium. Once in the right atrium, a long hollowneedle with a preformed curve and a sharpened distal tip can beintroduced through the dilator and can be forcibly inserted through thefossa ovalis. A radiopaque contrast material can be injected through theneedle to ensure the needle is in the left atrium as opposed to being inthe pericardial space, aorta, or other undesired location. Once theposition of the needle in the left atrium is confirmed, the dilator andsheath can be advanced over the needle and into the left atrium. Then,the needle and dilator can be removed leaving the sheath/introducer asan access point to the left atrium. An endocardial catheter containingone or more ablation elements and magnetic elements can be inserted intothe introducer and the catheter can be advanced into the left atrialchamber. The tip of the catheter can be advanced and steered to theapproximate site within the left atrium that is to be ablated. Any of avariety of steering techniques can be used to advance the endocardialablation catheter so as to bring the magnet of the ablation catheterinto sufficient proximity with the magnet of the guiding assembly, suchthat a magnetic attraction is established between the endocardialablation catheter and the guiding assembly. Suitable steering techniquesfor this process can be found in U.S. Pat. Nos. 5,820,591 and 7,115,122,the content of which are incorporated herein by reference.

According to some embodiments, a non-circumferential balloon orstructure can be placed over an ablation catheter section. For example,as depicted in FIG. 10A, an ablation assembly 1000 can include acatheter body 1010, an attraction element 1020 such as a magnet, anablation element 1030 such as an electrode, and a support structure 1040such as a non-circumferential balloon. The ablation electrode 1030 isplaced on the catheter body 1010 at a location 1012 where the balloon1040 does not extend circumferentially about the catheter body. Balloon1040 does extend circumferentially about the catheter body at a location1014 distal to the ablation element, and at a location 1016 proximal tothe ablation element. Hence, the support structure 1040 provides acavity or space 1018 between the electrode 1030 and the surface of apatient tissue 1050 when the ablation assembly 1000 is disposed at ornear the patient tissue 1050.

FIG. 10B shows a schematic illustration of an RF ablation cathetersystem including an electrode structure constructed in accordance withan embodiment of the present invention. RF ablation catheter 1000 bincludes a microporous electrode body 1120 b. The catheter 1000 b may beconnected to a RF generator 1200 b such as that described in Jackson etal., U.S. Pat. No. 5,383,874, the specification of which is fully andexpressly incorporated herein by reference. The RF generator 1200 bprovides the catheter 1000 b with a source of RF ablation energy. Thus,when operated, the RF generator 1200 b allows the physician to ablatetissue such as heart tissue in a controlled manner, resulting in atissue lesion with the desired characteristics. The catheter 1000 b mayalso be connected to a motor drive unit 1300 b and an ultrasonic (orother imaging) signal processor 1400 b, which when operated, allows thephysician to obtain images of the target tissue site, for example duringand subsequent to the ablation process. The catheter 1000 b can befunctionally divided into four regions: the operative distal catheterregion 1102 b, a deflectable catheter region 1104 b, a main catheterregion 1106 b, and an interfacing proximal catheter region 1107 b. Themicroporous electrode body 1120 b of the distal catheter region 102 brepresents the active component that provides the ablative capability tothe catheter 1000 b. The deflectable catheter region 1104 b providessteering capability to the catheter 1000 b, and particularly, providesan efficient and effective means for manipulating the distal catheterregion 1102 b. The main catheter region 1106 b provides the catheter1000 b with a useful length to deliver the distal catheter region 1102 bfrom the insertion point of the patient (for example, the femoral veinor artery) to the targeted tissue site. Lastly, the proximal catheterregion 1107 b, which includes a handle assembly 1132 b and a proximaladapter 1174 b, provides interfacing capability between the catheter1000 b and other instruments such as the RF generator 1200 b, motordrive unit 1300 b, and signal processor 1400 b, as well as a means forintroducing and removing fluids into and out of the catheter 1000 b.

FIG. 10C shows a partial side-elevational view of an embodiment of thecatheter of FIG. 10B, depicting the operative distal region, deflectableregion, and main region of the catheter. The catheter includes acatheter body 1108 c that carries a differing number of functionallumens and may have varying flexibility along its length. In thisregard, the catheter body 1108 c is composed of several extruded tubularelements affixed together in an axial arrangement. In particular, thecatheter body 1108 c may include first and second tubular elements 1110c, 1112 c, which form, in conjunction, the structure of the distalcatheter region 1102 c; a third tubular element 1114 c, which forms thestructure of the deflectable catheter region 1104 c; and a fourthtubular element 1116 c, which forms the structure of the main catheterregion 1106 c. It should be noted, however, that the catheter body 1108c may include any number of tubular elements to provide the desiredfunctionality to the catheter. The tubular elements 1110 c, 1112 c, 1114c, and 1116 c may be composed of a flexible and biocompatible material.In some cases, the second, third, and fourth tubular elements 1112 c,1114 c, and 1116 c may be composed of a nonconductive thermoplasticelastomer such as polyurethane. Optionally, if ultrasound imaging isused, the first tubular element 1110 c can be composed of a moreultrasound transparent material such as polyethylene. The tubularelements 1112 c, 1114 c and 1116 c can be suitably bonded together, forexample by means such as adhesive or thermal bonding to integrally formthe catheter body 1108 c. Additionally, heat shrink tubing (not shown)can be shrunk over the catheter body 1108 c to provide a more integralcatheter structure. The catheter body 1108 c can be variously sized,assuming the selected size allows the catheter body 1108 c to be routedthrough the vasculature of the patient to the targeted tissue site. Byway of a non-limiting example, a 9F catheter body 1108 c having a lengthof 100 cm can allow the catheter distal region 1102 c to be delivered tothe interior of the heart via the femoral vein or artery.

A catheter distal region can carry an ablation assembly, which includesa expandable-collapsible electrode body or structure and an actuatingelectrode, and for example, an electrode ring. The electrode body can besuitably mounted to the catheter body such that an interior region ofthe electrode body is in communication with substantially the entireexterior surface of a first tubular element, and at least a portion ofthe exterior surface of a second tubular element. The geometry of theelectrode body may be altered between a collapsed geometry and anenlarged, expanded geometry. An inflation medium under pressure can beused to fill the interior region, and thus, inflate and maintain theelectrode body in the expanded geometry. The inflation medium can beconveyed to and from the interior region of the electrode body via aninflation lumen formed through the catheter body, for example throughsecond, third and fourth tubular elements. The inflation lumen can be influid communication with the interior region of the electrode body viaan infusion hole formed through the wall of the catheter body, andoptionally, the wall of the second tubular element. With referencefurther to FIG. 10B, the inflation lumen can terminate proximally in thehandle assembly 1132 b, and optionally within a handle 1133 b of thehandle assembly 1132 b. The handle assembly 1132 b can further includean inflation port 1134 b, which can be in fluid communication with theinflation lumen within the handle 1133 b. Thus, inflation medium can beintroduced into, or removed from, the inflation port, providing aconvenient means of selectively inflating and deflating the electrodebody.

FIGS. 11 and 12 provide illustrations of an exemplary ablation assembly1100 according to embodiments of the present invention. The catheterdistal region 1102 carries an ablation element 1118 and anexpandable-collapsible body or structure 1120 that is mounted to thecatheter body 1108. A magnet 1109 or attraction element is coupled withor disposed within catheter body 1108. The geometry of the expandablebody 1120 may be altered between a collapsed geometry and an enlarged,expanded geometry (represented by broken line). In the illustratedembodiment, an inflation medium 1126 under pressure is used to fill theinterior region 1124, and thus, inflate and maintain the expandable body1120 in the expanded geometry. The inflation medium 1126 is conveyed toand from the interior region 1124 of the expandable body 1120 via aninflation lumen 1128 formed through the catheter body 1108. Theinflation lumen 1128 is in fluid communication with the interior region1124 of the expandable body 1120 via an infusion hole 1130 formedthrough the wall of the catheter body 1108, and specifically, the wallof a tubular element 1112.

An electrode ring 1122 is located between the first tubular element 1110and the second tubular element 1112. In particular, a proximal edge 1136of the first tubular element 1110 and a distal edge 1138 of the secondtubular element 1112 are affixed to the opposite edges of the electrodering 1122 by suitable means such as adhesive or thermal bonding,providing an integral connection between the first tubular element 1110and the second tubular element 1112. The electrode ring 1122 provides RFenergy to the ablation element 1118. In this regard, the electrode ring1122 is composed of a material having both a relatively high electricalconductivity and a relatively high thermal conductivity, e.g., stainlesssteel, gold, platinum, or platinum/iridium. To facilitate control of theRF energy delivery, the catheter 1100 may include one or moretemperature sensing elements 1152.

As shown here, at least a portion of the ablation electrode 1118 can beplaced along the catheter body 1108 at a location where the balloon 1120does not extend circumferentially about the catheter body. Balloon 1120does extend circumferentially about the catheter body at a location 1118a distal to the ablation element, and at a location 1118 b proximal tothe ablation element. Hence, the support structure 1120 provides acavity or space 1121 between the electrode 1118 and the surface of apatient tissue 1150 when the ablation assembly 1100 is disposed at ornear the patient tissue 1050. In some case, ablation electrode 1118 maybe mounted on an ablation electrode support 1119. Ablation assembliesmay also incorporate various additional features such as those describedin U.S. Pat. No. 6,893,437, the content of which is incorporated hereinby reference for all purposes.

With many currently available energy-based ablation devices, the appliedenergy heats not only the targeted heart tissue, but also blood. Suchuncontrolled heating of blood can coagulate blood or even create achar-like residue that results in emboli to the brain and other vitalorgans. In embodiments such as those described herein with reference toFIGS. 10 to 12 , for example, an endocardial ablation structure ortechnique can limit the amount of blood so heated and provides a morecontrolled lesion-making process. FIG. 10 depicts a partialside-elevation view of such a catheter, including an overview of theconstruction of the distal portion of the catheter. FIG. 11 provides alongitudinal cross-sectional view of the distal region of such acatheter. FIG. 12 illustrates a cross-sectional view of the distalsection of such a catheter, taken at the midpoint of the balloonstructure.

As depicted in FIG. 13 , a magnetic ablation structure 1310 can bedesigned to be used in conjunction with a magnetic positioning orguidance system 1320 placed on the epicardium of the left atrium wall1350. When the distal portion of the endocardial ablation catheter 1312of ablation structure 1310 is manipulated to be in proximity to theepicardial magnetic positioning or guidance system 1320, the forcebetween attraction elements 1322 and 1314 can cause the catheter 1312 torotate or self-position, thus orienting or placing the attractionelement or magnet 1314 and the ablation element or electrode 1316 asclose as possible to the epicardial surface. In other words, theablation electrode 1316 can automatically orient itself to be contactingor positioned very near the endocardium. In that position, the balloonstructure 1318 can isolate the ablation element 1316 from the bloodcontained within the left atrium. In some embodiments, saline can beslowly infused at the ablation electrode site to gradually force outresidual blood from the ablation zone 1319. The balloon 1318 can alsoserve to electrically and thermally isolate the ablation element 1316from the blood flowing in the atria, which has at least two benefits:the applied energy is directed only into the target cardiac tissue, andthe lack of conductive heat loss into the blood stream enables bettertemperature-feedback control of the applied lesion-making energy. Thefluid used to inflate the balloon 1318 could include a gas that isreadily absorbed into blood (C02 or N20) or the fluid could be saline.Such gases can provide beneficial thermal isolation properties. Salinecan provide beneficial neutral buoyancy properties.

FIG. 14A illustrates an exemplary electrode catheter for use inaccordance with embodiments of the present invention. As shown here, theelectrode catheter includes a catheter assembly 1440 having severalproximal leads 1442, a handle 1444 including a steering mechanism, and acatheter 1446. The handle 1444 includes a steering device which, inturn, can include a mechanism having a screw for tension adjustment anda guide wire which extends into the catheter 1446. The catheter 1446terminates at its distal end in a tip 1448. As depicted in FIG. 14B,distal tip 1448 can include an electrode 1450, several electrode rings1452, a control wire assembly 1454 which is operably connected to thesteering device of handle 1440, a thermistor (not shown) and a distaltube covering 1456. The thermistor can be used to determine thetemperature at the electrode tip 1450 to assist with RF application. Thedistal tip 1448 can include four, six or eight electrode rings 1452which are used for mapping. In the distal tip 1448, the electrode 1450can be formed of a magnetic material as described elsewhere herein. Thedistal tube cover 1456 can be formed of a material such as polyurethane.The electrode rings 1452 may be formed of any conventional electrodematerial, for example platinum. The outer diameter of the distal tip1440 can be varied as appropriate, for example about 6 to 8 French (F),or optionally about 7 F.

Another example of an ablation catheter 1448A is depicted in FIG. 14C.The catheter contains a control wire assembly 1454A, a distal tubecovering 1456A, and electrode rings 1452A equivalent to those of theexample in FIG. 14B. The catheter further contains an ablation tip 1464which may for example be formed of a platinum iridium alloy, which, inconjunction with the electrode rings 1452A supplies the ablationfunction. The ablation tip 1464 surrounds a permanent magnetic core1466. A soldered joint 1468 fastens the tip 1464 to the control wireassembly 1454A. FIG. 14D depicts a catheter 1448B that can function asan anchoring catheter, with a magnetic tip but for example withoutmapping or ablation functions (i.e., used in procedures involvingunipolar ablation). The catheter body 1456B, the control wire assembly1454B and the magnetic core 1466B may be equivalent or similar toembodiments described elsewhere herein. The distal tip covering 1460over the magnetic core 1466B can be formed of a biocompatible materialwhich does not interfere with the magnetic properties of the core 1466.Examples of such biocompatible materials include gold, platinum,platinum alloys, and plastics such as polyurethane or Teflon. A solderor pressure-fit joint 1468B can fasten the distal tip to the catheterbody 1456B by appropriate means such as soldering.

Embodiments of the present invention encompass systems and methods thatinvolve the use of an attraction element and an electrode disposed on anablation or guiding assembly. For example, a distal structure of acatheter may include an internal magnet, surrounded at least partiallyby a metal electrode. The metal electrode may include a nonmagnetic ornonmagnetizable material, such as platinum. For example, the metalelectrode may include a material that does not change structure in thepresence of a magnetic field, or that does not create or generate amagnetic field. In some embodiments, a system may include an interiorassembly for use near the endocardium, and an exterior assembly for usenear the epicardium. In some embodiments, an attraction element,optionally with an ablation element, is included on an interiorendocardial assembly, and an ablation element, optionally with andattraction element, is included on an exterior epicardial assembly. Insome embodiments, an ablation element, optionally with an attractionelement, is included on an interior endocardial assembly, and anattraction element, optionally with an ablation element, is included onan exterior epicardial assembly.

Embodiments of the present invention may utilize systems and methods forcontrolling tissue ablation using temperature sensing elements, forexample such as those described in U.S. Pat. No. 5,769,847, the contentof which is incorporated herein by reference.

While the exemplary embodiments have been described in some detail, byway of example and for clarity of understanding, those of skill in theart will recognize that a variety of modification, adaptations, andchanges may be employed. Hence, the scope of the present inventionshould be limited solely by the claims.

What is claimed is:
 1. A device for forming a lesion on an endocardialtissue of a patient's heart, the device comprising: a first elongatedcatheter comprising an ablation element, an expanding element, a firstattraction element, and an inflation lumen in fluid communication withan opening in the first elongated catheter, wherein the expandingelement extends circumferentially about part of the first elongatedcatheter, wherein the expanding element is in fluid communication withthe inflation lumen; a second elongated catheter comprising a secondattraction element, wherein the second attraction element is configuredto magnetically attract the first attraction element; and wherein theexpanding element expands to form a space between the ablation elementand the endocardial tissue when the first elongated catheter is placedwithin the heart.
 2. The device of claim 1, wherein the expandingelement isolates the ablation element from blood flowing in thepatient's heart.
 3. The device of claim 1, wherein the expanding elementcomprises a balloon.
 4. The device of claim 1, wherein the ablationelement is exposed at a location where the expanding element does notextend circumferentially about the first elongated catheter.
 5. Thedevice of claim 1, wherein the first elongated catheter furthercomprises a temperature sensing element.
 6. The device of claim 1,wherein magnetic attraction between the first and second attractionelements rotationally orients the ablation element relative to theendocardial tissue.
 7. A device for forming a lesion on an endocardialtissue of a patient's heart, the device comprising: an ablation assemblycomprising an ablation element, an expanding element, and a firstattraction element, wherein the expanding element extendscircumferentially about the ablation assembly at a first location and ata second location, wherein the first location and second location arespaced apart, wherein the ablation element is positioned between thefirst location and the second location; a guiding assembly comprising asecond attraction element, wherein the second attraction element isconfigured to magnetically attract the first attraction element; andwherein the expanding element expands to form a space between theablation element and the endocardial tissue when the ablation assemblyis placed within the heart.
 8. The device of claim 7, wherein theexpanding element isolates the ablation element from blood flowing inthe patient's heart.
 9. The device of claim 7, wherein the expandingelement comprises a balloon.
 10. The device of claim 7, wherein theablation assembly further comprises a temperature sensing element. 11.The device of claim 7, wherein magnetic attraction between the first andsecond attraction elements rotationally orients the ablation elementrelative to the endocardial tissue.